EP1023873B1 - Système de fixation rachidienne - Google Patents

Système de fixation rachidienne Download PDF

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Publication number
EP1023873B1
EP1023873B1 EP00101603A EP00101603A EP1023873B1 EP 1023873 B1 EP1023873 B1 EP 1023873B1 EP 00101603 A EP00101603 A EP 00101603A EP 00101603 A EP00101603 A EP 00101603A EP 1023873 B1 EP1023873 B1 EP 1023873B1
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EP
European Patent Office
Prior art keywords
connector
rod
pedicle screw
fixation system
pedicle
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
Application number
EP00101603A
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German (de)
English (en)
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EP1023873A2 (fr
EP1023873A3 (fr
Inventor
Ja-Kyo Gu
Howard S. An
Tae-Hong Lim
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Individual
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Individual
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Publication of EP1023873A3 publication Critical patent/EP1023873A3/fr
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7035—Screws or hooks, wherein a rod-clamping part and a bone-anchoring part can pivot relative to each other
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7041—Screws or hooks combined with longitudinal elements which do not contact vertebrae with single longitudinal rod offset laterally from single row of screws or hooks

Definitions

  • the present invention generally relates to a spinal fixation system for use in the immobilization of a sequence of spinal bones. More particularly, the present invention relates to a spinal fixation system which allows the implantation of the pedicle screws at the best anatomic location and orientation with flexibility of screw placement and alignment; easy and simple connection between the rod and the screws without application of excessive force to the spine and/or implants during assembly; the top-tightening mechanism to lock the assembly in place with better visibility and access to the spine and implants; a rigid segmental fixation for enhanced maintenance of correction and solid fusion process; and a low profile of the assembly.
  • the human spine is a complex columnar structure of vertebral bone and connective tissues.
  • the vertebrae, discs, and ligaments are intricately arranged, and the complex interaction amongst these structures provides flexibility for motion, spinal cord protection and distribution of body forces. In the diseased or injured state, this delicate equilibrium is disturbed and results in spinal pathologies.
  • the spinal disorders can be treated by a conservative nonsurgical method, such as medication, exercise and physical therapies.
  • some spinal disorders, such as degenerative instability, deformity, trauma, and tumors require a surgical intervention to treat pain induced by nerve root compression and unstable intervertebral joints.
  • the surgical procedures for the thoracolumbar spine involves the dissection of soft tissues and often the removal of load bearing structures, such as vertebral bone and discs to decompress the neural elements. Such decompression procedures lead to spinal instability and it is often necessary to fuse spinal segments to restore the stability.
  • Internal fixation with instrumentation accompanies surgical fusion to augment the bony fusion by achieving temporary but rigid fixation that provides a stable environment for bone fusion as well as a maintenance of corrected alignment of the spine.
  • Spinal implants can be classified as anterior or posterior instrumentation systems based upon the implanting location. Anterior implants are coupled to the anterior portion of the spine, while the posterior instrumentation is achieved using the posterior portion of the spine.
  • posterior implants using pedicle screws coupled by longitudinal rods has become more popular because of their capability of achieving a rigid fixation.
  • Such posterior implants generally comprise pairs of rods, which are aligned along the longitudinal axis of the spine, and which are then attached to the spinal column by screws which are inserted through the pedicles into respective vertebral bodies.
  • the surgical procedure to achieve a posterior fixation using pedicle screws and connecting rods generally includes the insertion of screws into pedicles in a predetermined angle and depth, temporary coupling of the rods to the screws, the proper correction of spinal curve, and the secure connection of rods to the screws for rigid fixation.
  • a considerable difficulty identified in this surgical procedure is associated with the coupling of a rod to a plurality of screws that are not well aligned in general because the angle and depth of the screw insertion should be determined by patients' anatomical and pathological conditions that may vary among spinal levels as well as among patients. It has been identified that attempts for addressing such a difficulty result in the application of unnecessarily excessive loads to the spinal column via the pedicle screws and the increased operation time, which are known to cause many complications associated with surgery.
  • the first method is the use of a connector comprising a hole to adapt a rod at one end and an oblong hole used for coupling with screws at the other end (ISOLA® Spinal System, AcroMed Corporation, Cleveland, OH).
  • This connector permits some freedom with respect to the distance between the rod and screw axes by the use of an oblong hole, but not with respect to angulation of the screw and the coupling element.
  • Such a polyaxial pedicle screw includes a pedicle screw and coupling element assembly which provides a polyaxial freedom of implantation angulation with respect to rod reception, and which comprises a reduced number of elements and thus correspondingly provides for expeditious implantation.
  • the screw and rod assembly should be locked using a nut oriented sideways (i.e., the tightening nut faces the lateral side of the patient during surgery), which is very inconvenient to perform in a very limited lateral operating space.
  • top-tightening mechanism i.e., the axis of tightening member faces the posterior side of the patient
  • the top-tightening mechanism provides better visibility and access than the side-tightening mechanism.
  • Polyaxial couplings of the screw and the rod used in previous inventions are also not likely to provide either sufficient joint-locking power to prevent the slippage and rotation of the screw with respect to the rod or the polyaxial freedom of implantation angulation.
  • the sufficient locking power in couplings is required to achieve a rigid fixation to provide a stable environment for successful bony fusion and also to maintain the correction until solid fusion occurs. Freedom in controlling both angulation and distance between the screw and the rod is required not only to reduce the surgery time but also to prevent the application of unnecessary stresses on the implant and the spine which may cause a failure in surgery.
  • US-A 5613968 discloses an orthopedic fixation device including a fixation ring, a universal pad, a threaded fixation element, and a fastening nut.
  • the universal pad contains a circular hole and is provided at one end with a protruding arcuate surface and at another end with a recessed arcuate surface concentric with the protruding arcuate surface.
  • the fastening nut is provided with a protruding or recessed arcuate surface located at one side facing the universal pad.
  • the threaded fixation element has an arresting portion which is provided with a protruding or recessed arcuate surface located at one side facing the universal pad. The protruding and recessed arcuate surfaces of the fastening nut and the threaded fixation element are engageable with the universal pad.
  • WO 94 00066 A discloses an osteosynthetic fixation device which consists of a securing component having a conical head section and an adjoining anchoring component designed for fixing in the bone, and a spherical segment-shaped slotted clamping component with a conical bore to receive the conical head section to clamp inside a connecting component having a spherical segment-shaped bore.
  • the securing component has an axially arranged tension component which permits the axial movement and wedging of the conical head section in the corresponding bore.
  • the securing device is suitable as a plate/screw system, an external or internal fixing device and especially for fixation of the spinal column.
  • it is the primary object of the present invention to provide a reliable, top-tightening spinal fixation system comprising pedicle screws, rods, and connecting and tightening members, which provides freedom of implantation not only with respect to angulation of the screw but also with respect to the distance between the screw head and the rod using a reduced number of elements for easy, simple and expeditious implantation.
  • a posterior transpedicular instrumentation system comprising:
  • the round portion in the spherical head of the pedicle screw and the recessed hemispherical wall in the support portion of the connector form a spherical joint (with which the connector) and thus the rod can be placed into the required angular position.
  • the use of connectors with different sizes provides lateral adjustment of the rod that can be located at various distances from the pedicle screws because of anatomic variations.
  • the use of the spherical head of the pedicle screw and the hemispherical wall having slightly different diameters improves the locking power and provides a rigid fixation.
  • a similar locking mechanism is employed to achieve a rigid connection of the rod to the connector.
  • a pedicle screw 10 to be implanted into a selected pedicle of the patient's vertebrae comprises a stem 11 protruded from a top portion thereof, a spherical head 13 formed below the stem 11, and a threaded shaft 15.
  • the stem 11 has threads 12 on its outer surface.
  • the spherical head 13 has six cut portions 16 along its equator line so as to make a hexagonal shape in its middle portion for inserting the pedicle screw 10 using a spanner, wrench or the likes.
  • a round portion 14 is the upper portion of the spherical head 13, which serves as a part of ball and socket joint between the pedicle screw 10 and a connector 30 which will be described below.
  • the shaft 15 of the pedicle screw 10 although shown to be like a bolt in FIG. 1, is used for being anchored into and holding the vertebra and will be, therefore, able to have any type of threads which is adequate for securely holding the bone.
  • the connector 30 in FIG. 1, which connects a rod 20 to the pedicle screw 10 comprises a rod reception portion on one end and a screw reception portion on the other end.
  • the rod reception portion of the connector 30 has a rod passage 31 to receive the rod 20 therethrough and a set member bore 32 formed in an upper portion of the rod reception portion of the connector 30 and intersecting perpendicular to the rod passage 31.
  • the surface of the set member bore 32 is threaded to be engaged with a set member 40 which has a threaded outer surface for secure tightening of the rod 20 to the connector 30.
  • the set member 40 has a recess 41 (See FIG. 1) of hexagonal cross-section for insertion into the set member bore using an allen wrench.
  • the length of the set member should be short enough not to protrude from the upper surface of the set member bore 32 of the connector 30 to lower the profile of the complete assembly.
  • the screw reception portion of the connector 30 comprises a support portion 33 of a hemispherical shape which has an opening 34 formed to receive the stem 11 of the pedicle screw 10 and a recessed hemispherical wall 35 therein.
  • the diameter of the recessed hemispherical wall 35 is slightly less than that of the round portion 14 of the upper portion of the spherical head 13.
  • the stem 11 of the pedicle screw 10 which extends through the opening 34 is engaged to a fixing cap 50.
  • the fixing cap 50 in FIG. 1 comprises a stem bore 52 which is a threaded hole formed to engage the stem 11 of the pedicle screw 10 and a recessed spherical bottom surface 51 formed to be hollowed inside its surface thereof.
  • the round portion 14 formed at the upper portion of the pedicle screw 10 is held in the recessed hemispherical wall 35 of the opening 34 during assembly.
  • the round portion 14 of the pedicle screw 10 and the recessed hemispherical wall 35 of the support portion 33 of the connector 30 are formed in almost the same spherical surfaces.
  • the connector 30 is freely rotated with respect to the pedicle screw 10 before tightening, and thus the pedicle screw 10 and the connector 30 are polyaxially engaged regardless of the insertion angle of the pedicle screw 10.
  • the use of the connector 30 with different distances between the rod and screw reception portions provides the capability for lateral adjustment in controlling the rod position (See FIG. 3).
  • the diameter of the round portion 14 of the pedicle screw 10 is a little larger in fine tolerance than that of the inner hemispherical wall 35 of the connector 30.
  • Such a ball-and-socket like connection with imperfectly matched surface contact provides an improved prevention of slippage within the joint compared with a conventional ball and socket joint with a perfectly matched surface contact.
  • an imperfectly matched surface contact induces the deformation of the support portion 33 of the hemispherical shell shape when the fixing cap 50 is tightened.
  • the deformed support portion 33 of the connector 30 made of an elastic titanium alloy tends to return back to the original shape, which pushes the fixing cap 50.
  • This elastic (or springback) force prevents loosening of the fixing cap 50, which eliminates the use of an additional nut which has been used in previous spinal fixation systems in order to prevent loosening.
  • the cross section of the rod passage 31 is made to have an outer boundary of two circles of slightly different diameters located at a slightly eccentric center positions so as to form a hole of imperfect-circular cross-section.
  • the implantation procedure of the present invention to achieve the surgical construct as shown in FIG. 6 is described hereafter.
  • the pedicle screw 10 is inserted into the pedicle according to the best anatomic location and orientation at each spinal level without considering the alignment of screws for later attachment of the rod to the pedicle screws.
  • the rod 20 is engaged to the connector 30 through the rod passage 31 and temporarily nested in the rod passage 31 by applying a small compressive load using the set member 40.
  • the rod-connector assembly is located on the spherical head 13 of the pedicle screw 10, and the fixing cap 50 is engaged to the stem 11 of the pedicle screw 10. Then, the assembly is locked in place by tightening the fixing cap 50 and the set member 40.
  • the use of the connector 30 allows the location of the rod 20 lateral to the pedicle screw 10, which lowers the profile of the present invention significantly.
  • the variability in screw placement and screw-rod connection achieved in the present invention allows a physician to implant the screw according to the best anatomic location and orientation with no need for considering the alignment of the pedicle screws. These features also minimize the need for precise bending of the rod 20 which has been required for the implantation of some spinal fixation systems which do not have such variability in screw-rod connection.
  • the invention provides a spinal fixation system for use in the immobilization of a sequence of spinal bones, comprising a plurality of pedicle screws (10), a pair of rods (20), and connectors (30).
  • the pedicle screw has a spherical head (13) having a round portion (14) at an upper portion of the spherical head, a threaded shaft (15) for insertion through the pedicles, and a threaded stem (11) on the top of the spherical head.
  • the connector (30) has a rod passage (31) for receiving the rod (20) therethrough, a set member bore (32) formed in an upper portion of the connector, and a support portion (33) having an opening formed for adapting the stem of the pedicle screw and a recessed hemispherical wall (35).
  • a spherical joint at the pedicle screw and the connector allows the multi-directional adjustment capability of the connector so that the screws can be implanted in any angulation with no need of having the screws well aligned.
  • the spherical head (13) of the pedicle screw (10) and the hemispherical wall (35) have slightly different diameters which improve the locking power and provide a rigid fixation.
  • a rigid coupling is achieved between the rod (20) and the connector (30) by making the cross-section of the rod passage (31) as an imperfect circular shape which allows the three point contact between the rod and the rod passage.
  • the assembly is locked in place by tightening the fixing cap (50) and a set member (40) from the posterior aspect of the spine.

Claims (10)

  1. Système de fixation rachidienne comprenant :
    une pluralité de vis de pédicule (10), chaque vis de pédicule (10) ayant une tige (11) dépassant d'une partie supérieure de celle-ci, la tige ayant des filets sur sa surface extérieure, une tête sphérique (13) formée sous la tige (11), et un axe fileté (15) qui est inséré dans le pédicule des vertèbres ;
    une paire de barres (20) situées dans la face latérale du rachis et connectées aux vis de pédicule (10), les barres (20) s'étendant des deux côtés des apophyses épineuses le long de la longueur de la colonne vertébrale pour empêcher le déplacement des vertèbres lésées ou décompressées ;
    un certain nombre de connecteurs (30) pour coupler chacune des vis de pédicule (10) aux barres avec réglage latéral, chaque connecteur ayant un passage de barre (31) formé pour recevoir la barre (20) à travers celui-ci et une partie de support (33) d'une coquille hémisphérique qui offre une liberté de rotation en couplant la vis de pédicule (10) et le connecteur (30), la partie de support (33) ayant une ouverture formée à travers le milieu de la partie de support (33) pour maintenir la tige (11) de la vis de pédicule (10) et une paroi hémisphérique en creux (35) dans celle-ci ; et
    un certain nombre de chapeaux de fixation (50), chaque chapeau de fixation ayant un alésage de tige (52) formé pour s'adapter à la tige (11) de la vis de pédicule (10) à travers celui-ci et une surface inférieure hémisphérique en creux (51),
       caractérisé par un certain nombre d'éléments définis (40), chaque élément défini étant inséré dans un alésage d'élément défini (32) du connecteur (30) pour fixer la barre (20) insérée dans le passage de barre (31) du connecteur, l'alésage d'élément défini (32) étant formé dans une partie supérieure du connecteur (30) pour couper perpendiculairement au passage de barre (31), dans lequel la tête sphérique (13) a six parties découpées (16) le long de sa ligne d'équateur de manière à créer une forme hexagonale dans la partie du milieu.
  2. Système de fixation rachidienne selon la revendication 1, dans lequel la tête sphérique (13) a une partie ronde (14) à sa partie supérieure, la partie ronde servant de partie d'articulation à rotule entre la vis de pédicule (10) et le connecteur (30).
  3. Système de fixation rachidienne selon l'une quelconque des revendications précédentes, dans lequel l'élément défini (40) a une surface extérieure filetée pour le serrage sûr de la barre (20) au connecteur (30) et un creux (41) d'une coupe transversale hexagonale formée à la partie supérieure de celui-ci.
  4. Système de fixation rachidienne selon l'une quelconque des revendications précédentes, dans lequel l'élément défini (40) a une longueur suffisamment courte pour ne pas dépasser de la surface supérieure de l'alésage d'élément défini (32) du connecteur (30) de manière à abaisser le profil de l'ensemble complet.
  5. Système de fixation rachidienne selon l'une quelconque des revendications précédentes, dans lequel l'alésage de l'élément défini (32) du connecteur (30) est fileté sur sa surface interne pour être engagé dans l'élément défini (40).
  6. Système de fixation rachidienne selon la revendication 2, dans lequel la partie ronde (14) est formée dans presque la même surface sphérique que la paroi hémisphérique en creux (35) de la partie de support (33) du connecteur (30), de sorte que l'on peut faire pivoter le connecteur par rapport à la vis de pédicule (10) dans toutes les directions avant serrage.
  7. Système de fixation rachidienne selon l'une quelconque des revendications précédentes, dans lequel le connecteur (30) est fait d'alliage de titane avec une force élastique et tend à retourner à sa forme initiale.
  8. Système de fixation rachidienne selon l'une quelconque des revendications précédentes, dans lequel le connecteur (30) a différentes distances entre le passage de la barre (31) et la partie de support (33) de celui-ci pour offrir la capacité de réglage latéral en contrôlant la position de la barre.
  9. Système de fixation rachidienne selon la revendication 2, dans lequel le diamètre de la partie arrondie de la vis de pédicule (10) est un peu plus important en tolérance fine que celui de la paroi hémisphérique interne du connecteur (30) de sorte qu'un contact de surface adapté de manière imparfaite entre la vis de pédicule (10) et le connecteur (30) se produit, et dans lequel le contact de surface adapté de manière imparfaite induit la déformation de la partie de support (33) de la forme de coquille hémisphérique quand on serre le chapeau de fixation (50), et propose une fixation ferme entre la vis de pédicule (10) et le connecteur (30).
  10. Système de fixation rachidienne présenté dans l'une quelconque des revendications précédentes, dans lequel le passage de barre (31) est fait pour avoir une limite externe de deux cercles de diamètres légèrement différents situés à des positions centrales légèrement excentriques, et dans lequel au moins un contact en trois points se produit entre la barre (20) et le passage de barre (31) en serrant le chapeau de fixation (50) indépendamment de l'état de courbure de la barre.
EP00101603A 1999-01-30 2000-01-27 Système de fixation rachidienne Expired - Lifetime EP1023873B1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR1019990003161A KR100324698B1 (ko) 1999-01-30 1999-01-30 척추고정장치
KR9903161 1999-01-30

Publications (3)

Publication Number Publication Date
EP1023873A2 EP1023873A2 (fr) 2000-08-02
EP1023873A3 EP1023873A3 (fr) 2003-05-02
EP1023873B1 true EP1023873B1 (fr) 2004-10-06

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EP00101603A Expired - Lifetime EP1023873B1 (fr) 1999-01-30 2000-01-27 Système de fixation rachidienne

Country Status (6)

Country Link
US (1) US6280443B1 (fr)
EP (1) EP1023873B1 (fr)
KR (1) KR100324698B1 (fr)
AT (1) ATE278361T1 (fr)
DE (1) DE60014462T2 (fr)
ES (1) ES2228310T3 (fr)

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US8425563B2 (en) 2006-01-13 2013-04-23 Depuy International Ltd. Spinal rod support kit
US9101416B2 (en) 2003-01-24 2015-08-11 DePuy Synthes Products, Inc. Spinal rod approximator

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US6280443B1 (en) 2001-08-28
DE60014462T2 (de) 2006-05-18
KR20000052241A (ko) 2000-08-16
ATE278361T1 (de) 2004-10-15
DE60014462D1 (de) 2004-11-11
KR100324698B1 (ko) 2002-02-27
ES2228310T3 (es) 2005-04-16
EP1023873A2 (fr) 2000-08-02
EP1023873A3 (fr) 2003-05-02

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